The Meddev Solutions EU MDR Guidebook
With the EU Medical Device Regulation (MDR) looming and requiring implementation by May 2020, we have created a guidebook and training course to help you get prepared.
For anyone involved in ensuring compliance with the EU MDR, it is the ‘go-to’ reference and tool kit, intended to be your companion to reference time and time again.
It contains a number of useful tools and tables to guide you through the MDR, such as:
device classification and their differences from the MDD
QMS requirements and how they align with ISO 13485
technical documentation requirements
clinical data requirements, including a handy checklist
general safety and performance requirements tables
annex and article guide
"An essential tool for any device manufacturer selling into Europe!"
"A very well presented course with excellent examples throughout, the Guidebook is the cherry on the cake!"
Don't forget: Our 2-day Medical Device Regulation (MDR) training course includes your own copy of the MDR Guidebook to take away! View available dates here
E-book available now!
The Regulatory Affairs Professionals Society (RAPS) has teamed up with us to offer our MDR Guidebook in a convenient e-book format.
RAPS Member: $175
*Note: Internet access is required to read all RAPS e-books. E-books cannot be downloaded for offline use.